There are many instruments or components in medical device products that come into direct or indirect contact with the human body, and during the process of contact with organisms, there may be a series of biological reactions and device (or material) reactions that do not correspond to the purpose of application, and the results of these reactions may jeopardize the health of users and may also affect the normal function of medical devices, so medical devices, before clinical application, need to carry out systematic biological evaluation.
Bacterial endotoxin testing | Chromosomal aberration test in mammalian cells in vitro |
Hemolysis assay | Erythrocyte micronucleus assay |
Pyrogen examination | Cytotoxicity assay |
Acute systemic toxicity testing | Animal stimulation test |
Subacute systemic toxicity testing | Intradermal stimulation test |
Subchronic systemic toxicity test | Skin sensitization test |
Bacterial reverse mutation assay | Subcutaneous implantation for local reaction test |
Ocular irritation test | Bone implant local response test |
Intramuscular implant local reaction test | Rectal irritation test |
Vaginal stimulation test | Penile stimulation test |
